FDA Panel OKs First COVID Pill 'Molnupiravir' From Merck
A panel for the U.S. Food and Drug Administration (FDA) narrowly backed a "first-of-its-kind" COVID pill from pharmaceutical company Merck on Tuesday.
The panel voted 13-10 with the greater number in favor that the drug's benefits outweigh the risks, including potential birth defects if taken during pregnancy, New York Post reported.
The vote specifically backed the COVID pill for adults with mild to moderate coronavirus symptoms who face the greater risk. The demographic includes older people and those who have the condition of obesity and asthma.
Despite the panel's backing on the said medication, the FDA is not bound by the panel's decision. The agency is expected to make its own decision about Merck's COVID pill by the year's end.
According to NBC News, the molnupiravir works by stopping the virus' genetic material from being replicated accurately.
The said drug "fools" the polymerase responsible for replicating the RNA of the coronavirus to make sure it inserts errors or mutations. The said mutations will get replicated over and over until there are so many mutations making the virus no longer survive.
FDA Panel Comments on Merck's COVID Pill's Effect on Pregnancy
Although the medication from Merck was backed by the FDA panel, some of the experts who voted on Tuesday expressed their concern about the pill when it comes to pregnant women.
Earlier on Tuesday, FDA scientists informed the panelists that Merck studies in rats showed that the drug caused "toxicity" and birth defects when given at very high doses. The FDA staffers then concluded that the COVID pill, medically known as molnupiravir, "may cause fetal harm when administered to pregnant individuals."
"I think the FDA should not approve it [COVID Pill] for the use in pregnant women except under really exceptional circumstances," David Eastman, a biology professor from the University of California, Riverside, said as he voted yes on the pill.
Meanwhile, other voters on Tuesday said that the decision to take the pill should be left up to the pregnant person, along with a medical counselor who may help inform their decision.
However, Eastman said that he thinks that the FDA should limit the use of the COVID pill to "high-risk individuals."
"I don't think you can ethically tell a woman with COVID-19 that she can't have the drug if she's decided that's what she needs," a panel member and staffer with the Centers for Disease Control and Prevention (CDC) said.
FDA Panel 'Frustrated' Over Covid Pill's Effectiveness on New Variants such as Omicron
New York Post reported that although the pill was approved by the FDA panel, the said panel was "frustrated" whether they will back the treatment for millions of Americans.
This is because Merck has not yet specifically tested their drug against the new Omicron variant. However, the pharmaceutical company said that their drug has "some potency" based on its effectiveness against other strains of coronavirus.
"With no data saying it works with new variants, I really think we need to be careful about saying that this is the way to go," Dr. David Hardy from Charles Drew University School of Medicine and Science said.
Last week, the final study of the COVID pill from Merck showed that molnupiravir diminished the hospitalizations and death by 30 percent among adults positive from COVID when compared to adults taking placebo.
This article is owned by Latin Post.
Written By: Joshua Summers
WATCH: FDA Panel Recommends Merck Covid Pill for Emergency Use - From CNBC Television
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